Delivery methods and devices for implantable bronchial isolation devices

ABSTRACT

Disclosed is a sizing device for sizing an inside diameter of a lung passageway. The device includes an elongate shaft configured for positioning in the lung passageway and a sizing element at the distal end of the shaft. The sizing element defines a range of transverse dimensions that correspond to a range of transverse dimensions suitable for use with a predetermined set of bronchial isolation devices. The device is used to determine the suitability of a bronchial isolation device for use in the lung passageway prior to using a separate delivery catheter to deliver the bronchial isolation device into the lung passageway.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/174,040, filed Jun. 29, 2005, which is a continuation-in-part ofco-pending U.S. patent application Ser. No. 10/723,273, filed Nov. 25,2003, which claims priority of U.S. Provisional Patent Application No.60/429,902, filed Nov. 27, 2002. Priority of the aforementioned filingdates is hereby claimed, and the disclosures of the aforementionedpatent applications are hereby incorporated by reference in theirentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to methods and devices for use inperforming pulmonary procedures and, more particularly, to devices andprocedures for treating lung diseases.

2. Description of the Related Art

Certain pulmonary diseases, such as emphysema, reduce the ability of oneor both lungs to fully expel air during the exhalation phase of thebreathing cycle. Such diseases are accompanied by chronic or recurrentobstruction to air flow within the lung. One of the effects of suchdiseases is that the diseased lung tissue is less elastic than healthylung tissue, which is one factor that prevents full exhalation of air.During breathing, the diseased portion of the lung does not fully recoildue to the diseased (e.g., emphysematic) lung tissue being less elasticthan healthy tissue. Consequently, the diseased lung tissue exerts arelatively low driving force, which results in the diseased lungexpelling less air volume than a healthy lung.

The problem is further compounded by the diseased, less elastic tissuethat surrounds the very narrow airways that lead to the alveoli, whichare the air sacs where oxygen-carbon dioxide exchange occurs. Thediseased tissue has less tone than healthy tissue and is typicallyunable to maintain the narrow airways open until the end of theexhalation cycle. This traps air in the lungs and exacerbates thealready-inefficient breathing cycle. The trapped air causes the tissueto become hyper-expanded and no longer able to effect efficientoxygen-carbon dioxide exchange.

In addition, hyper-expanded, diseased lung tissue occupies more of thepleural space than healthy lung tissue. In most cases, a portion of thelung is diseased while the remaining part is relatively healthy and,therefore, still able to efficiently carry out oxygen exchange. Bytaking up more of the pleural space, the hyper-expanded lung tissuereduces the amount of space available to accommodate the healthy,functioning lung tissue. As a result, the hyper-expanded lung tissuecauses inefficient breathing due to its own reduced functionality andbecause it adversely affects the functionality of adjacent healthytissue.

Lung reduction surgery is a conventional method of treating emphysema.However, such a conventional surgical approach is relatively traumaticand invasive, and, like most surgical procedures, is not a viable optionfor all patients.

Some recently proposed treatments for emphysema or other lung ailmentsinclude the use of devices that isolate a diseased region of the lung inorder to modify the air flow to the targeted lung region or to achievevolume reduction or collapse of the targeted lung region. According tosuch treatments, one or more bronchial isolation devices are implantedin airways feeding the targeted region of the lung. The bronchialisolation device regulates fluid flow through the bronchial passagewayin which the bronchial isolation device is implanted. The bronchialisolation devices can be, for example, one-way valves that allow flow inthe exhalation direction only, occluders or plugs that prevent flow ineither direction, or two-way valves that control flow in bothdirections.

The following references describe exemplary bronchial isolation devices:U.S. Pat. No. 5,954,766 entitled “Body Fluid Flow Control Device”; U.S.patent application Ser. No. 09/797,910, entitled “Methods and Devicesfor Use in Performing Pulmonary Procedures”; and U.S. patent applicationSer. No. 10/270,792, entitled “Bronchial Flow Control Devices andMethods of Use”. The foregoing references are all incorporated byreference in their entirety and are all assigned to Emphasys Medical,Inc., the assignee of the instant application.

The bronchial isolation device can be implanted in a target bronchialpassageway using a delivery catheter that is placed through the trachea(via the mouth or the nasal cavities) and to the target location in thebronchial passageway. It would be advantageous to develop improvedmethods and devices for delivering bronchial isolation devices into thelung of a patient.

Disclosed is a device for sizing an inside diameter of a lungpassageway. In one aspect, the sizing device comprises an elongate shaftconfigured for positioning in the lung passageway and a sizing elementat the distal end of the shaft. The sizing element defines a range oftransverse dimensions that correspond to a range of transversedimensions suitable for use with a predetermined set of bronchialisolation devices. The device is used to determine the suitability of abronchial isolation device for use in the lung passageway prior to usinga separate delivery catheter to deliver the bronchial isolation deviceinto the lung passageway.

In another aspect, there is disclosed a device for sizing an insidediameter of a lung passageway. The device comprises an elongate shaftconfigured for positioning in the lung passageway and a sizing elementdisposed on a distal end of the shaft. The sizing element provides anindication as to the size of the lung passageway for selection of abronchial isolation device to be inserted into the lung passageway.

Other features and advantages of the present invention should beapparent from the following description of various embodiments, whichillustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an anterior view of a pair of human lungs and a bronchialtree with a bronchial isolation device implanted in a bronchialpassageway to bronchially isolate a region of the lung.

FIG. 2 illustrates an anterior view of a pair of human lungs and abronchial tree.

FIG. 3 illustrates a lateral view of the right lung.

FIG. 4 illustrates a lateral view of the left lung.

FIG. 5 illustrates an anterior view of the trachea and a portion of thebronchial tree.

FIG. 6 shows a perspective view of a bronchoscope.

FIG. 7 shows an enlarged view of a distal region of a bronchoscope.

FIG. 8 shows a delivery catheter for delivering a bronchial isolationdevice to a target location in a body passageway.

FIG. 9 shows a perspective view of a distal region of the deliverycatheter.

FIG. 10A shows a plan, side view of the distal region of the deliverycatheter.

FIG. 10B shows a cross-sectional view of the delivery catheter alongline 10B-10B of FIG. 10A.

FIG. 11A shows the delivery catheter containing a bronchial isolationdevice in a housing, which is positioned at a location L of a bronchialpassageway.

FIG. 11B shows the delivery catheter and the deployed bronchialisolation device at the location L of the bronchial passageway.

FIG. 12 shows a cross-sectional view of a delivery catheter deployed ina bronchial location that requires the delivery catheter's distal end tobend at an acute angle.

FIG. 13 shows a cross-sectional view of the distal end of the deliverycatheter with a limited-travel flange fully retracted into the deliveryhousing.

FIG. 14 shows a cross-sectional view of the distal end of the deliverycatheter with a limited-travel flange fully extended.

FIG. 15 shows a side view of one embodiment of an actuation handle ofthe delivery catheter.

FIG. 16 shows a cross-sectional, side view of the actuation handle ofFIG. 15 with an actuation member in an initial position.

FIG. 17 shows a cross-sectional, side view of a portion of the actuationhandle of FIG. 15 with the actuation member distal of the initialposition.

FIG. 18 shows an enlarged view of the distal region of the bronchoscopewith the delivery catheter's distal end protruding outward from theworking channel.

FIG. 19 shows another embodiment of the delivery catheter handleconfigured for transcopic delivery.

FIG. 20 shows the delivery catheter of FIG. 19 positioned within theworking channel of the bronchoscope with the catheter handle protrudingfrom the bronchoscope.

FIG. 21 shows an embodiment of the delivery catheter that includes adeployment sheath.

FIG. 22 shows a partial view of the delivery catheter of FIG. 21positioned through an anesthesia adapter.

FIG. 23 shows a sizing catheter with a sizing element on a distal end ofthe catheter.

FIG. 24 shows an enlarged view of one embodiment of the sizing element.

FIG. 25 shows a side view of a sizing element having a depth measuringextension.

FIG. 26 shows a perspective view of a handle of the sizing catheter, thehandle including a cavity that receives at least a portion of the sizingelement.

DETAILED DESCRIPTION OF THE INVENTION

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of skill in theart to which the invention(s) belong. It should be noted that thevarious devices and methods disclosed herein are not limited to thetreatment of emphysema, and may be used for various other lung diseases.

Disclosed are various devices and methods for delivering one or morebronchial isolation devices (which are sometimes referred to herein asflow control devices) to a location in a bronchial passageway. Thebronchial isolation device is delivered to a target location in thebronchial passageway by mounting the bronchial isolation device in ahousing at the distal end of a delivery catheter and then inserting thedelivery catheter into the bronchial passageway. Once the housing ispositioned at a target location in the bronchial passageway, thebronchial isolation device is ejected from the housing and deployedwithin the passageway. In the example shown in FIG. 1, the distal end ofthe delivery catheter 110 is inserted into the patient's mouth or nose,through the trachea, and down to a target location in the bronchialpassageway 517. For clarity of illustration, FIG. 1 does not show thehousing in which the device is contained.

The following references describe exemplary bronchial isolation devicesand delivery devices: U.S. Pat. No. 5,954,766 entitled “Body Fluid FlowControl Device”; U.S. patent application Ser. No. 09/797,910, entitled“Methods and Devices for Use in Performing Pulmonary Procedures”; U.S.patent application Ser. No. 10/270,792, entitled “Bronchial Flow ControlDevices and Methods of Use”; and U.S. patent application Ser. No.10/448,154, entitled “Guidewire Delivery of Implantable BronchialIsolation Devices in Accordance with Lung Treatment”. The foregoingreferences are all incorporated by reference in their entirety and areall assigned to Emphasys Medical, Inc., the assignee of the instantapplication.

Exemplary Lung Regions. Throughout this disclosure, reference is made tothe term “lung region”. As used herein, the term “lung region” refers toa defined division or portion of a lung. For purposes of example, lungregions are described herein with reference to human lungs, wherein someexemplary lung regions include lung lobes and lung segments. Thus, theterm “lung region” as used herein can refer, for example, to a lung lobeor a lung segment. Such nomenclature conform to nomenclature forportions of the lungs that are known to those skilled in the art.However, it should be appreciated that the term “lung region” does notnecessarily refer to a lung lobe or a lung segment, but can refer tosome other defined division or portion of a human or non-human lung.

FIG. 2 shows an anterior view of a pair of human lungs 210, 215 and abronchial tree 220 that provides a fluid pathway into and out of thelungs 210, 215 from a trachea 225, as will be known to those skilled inthe art. As used herein, the term “fluid” can refer to a gas, a liquid,or a combination of gas(es) and liquid(s). For clarity of illustration,FIG. 2 shows only a portion of the bronchial tree 220, which isdescribed in more detail below with reference to FIG. 5.

Throughout this description, certain terms are used that refer torelative directions or locations along a path defined from an entrywayinto the patient's body (e.g., the mouth or nose) to the patient'slungs. The path of airflow into the lungs generally begins at thepatient's mouth or nose, travels through the trachea into one or morebronchial passageways, and terminates at some point in the patient'slungs. For example, FIG. 2 shows a path 202 that travels through thetrachea 225 and through a bronchial passageway into a location in theright lung 210. The term “proximal direction” refers to the directionalong such a path 202 that points toward the patient's mouth or nose andaway from the patient's lungs. In other words, the proximal direction isgenerally the same as the expiration direction when the patientbreathes. The arrow 204 in FIG. 2 points in the proximal or expiratorydirection. The term “distal direction” refers to the direction alongsuch a path 202 that points toward the patient's lung and away from themouth or nose. The distal direction is generally the same as theinhalation or inspiratory direction when the patient breathes. The arrow206 in FIG. 2 points in the distal or inhalation direction.

The lungs include a right lung 210 and a left lung 215. The right lung210 includes lung regions comprised of three lobes, including a rightupper lobe 230, a right middle lobe 235, and a right lower lobe 240. Thelobes 230, 235, 240 are separated by two interlobar fissures, includinga right oblique fissure 226 and a right transverse fissure 228. Theright oblique fissure 226 separates the right lower lobe 240 from theright upper lobe 230 and from the right middle lobe 235. The righttransverse fissure 228 separates the right upper lobe 230 from the rightmiddle lobe 235.

As shown in FIG. 2, the left lung 215 includes lung regions comprised oftwo lobes, including the left upper lobe 250 and the left lower lobe255. An interlobar fissure comprised of a left oblique fissure 245 ofthe left lung 215 separates the left upper lobe 250 from the left lowerlobe 255. The lobes 230, 235, 240, 250, 255 are directly supplied airvia respective lobar bronchi, as described in detail below.

FIG. 3 is a lateral view of the right lung 210. The right lung 210 issubdivided into lung regions comprised of a plurality ofbronchopulmonary segments. Each bronchopulmonary segment is directlysupplied air by a corresponding segmental tertiary bronchus, asdescribed below. The bronchopulmonary segments of the right lung 210include a right apical segment 310, a right posterior segment 320, and aright anterior segment 330, all of which are disposed in the right upperlobe 230. The right lung bronchopulmonary segments further include aright lateral segment 340 and a right medial segment 350, which aredisposed in the right middle lobe 235. The right lower lobe 240 includesbronchopulmonary segments comprised of a right superior segment 360, aright medial basal segment (which cannot be seen from the lateral viewand is not shown in FIG. 3), a right anterior basal segment 380, a rightlateral basal segment 390, and a right posterior basal segment 395.

FIG. 4 shows a lateral view of the left lung 215, which is subdividedinto, lung regions comprised of a plurality of bronchopulmonarysegments. The bronchopulmonary segments include a left apical segment410, a left posterior segment 420, a left anterior segment 430, a leftsuperior segment 440, and a left inferior segment 450, which aredisposed in the left lung upper lobe 250. The lower lobe 255 of the leftlung 215 includes bronchopulmonary segments comprised of a left superiorsegment 460, a left medial basal segment (which cannot be seen from thelateral view and is not shown in FIG. 4), a left anterior basal segment480, a left lateral basal segment 490, and a left posterior basalsegment 495.

FIG. 5 shows an anterior view of the trachea 325 and a portion of thebronchial tree 220, which includes a network of bronchial passageways,as described below. The trachea 225 divides at a lower end into twobronchial passageways comprised of primary bronchi, including a rightprimary bronchus 510 that provides direct air flow to the right lung210, and a left primary bronchus 515 that provides direct air flow tothe left lung 215. Each primary bronchus 510, 515 divides into a nextgeneration of bronchial passageways comprised of a plurality of lobarbronchi. The right primary bronchus 510 divides into a right upper lobarbronchus 517, a right middle lobar bronchus 520, and a right lower lobarbronchus 422. The left primary bronchus 415 divides into a left upperlobar bronchus 525 and a left lower lobar bronchus 530. Each lobarbronchus 517, 520, 522, 525, 530 directly feeds fluid to a respectivelung lobe, as indicated by the respective names of the lobar bronchi.The lobar bronchi each divide into yet another generation of bronchialpassageways comprised of segmental bronchi, which provide air flow tothe bronchopulmonary segments discussed above.

As is known to those skilled in the art, a bronchial passageway definesan internal lumen through which fluid can flow to and from a lung orlung region. The diameter of the internal lumen for a specific bronchialpassageway can vary based on the bronchial passageway's location in thebronchial tree (such as whether the bronchial passageway is a lobarbronchus or a segmental bronchus) and can also vary from patient topatient. However, the internal diameter of a bronchial passageway isgenerally in the range of 3 millimeters (mm) to 10 mm, although theinternal diameter of a bronchial passageway can be outside of thisrange. For example, a bronchial passageway can have an internal diameterof well below 1 mm at locations deep within the lung. The internaldiameter can also vary from inhalation to exhalation as the diameterincreases during inhalation as the lungs expand, and decreases duringexhalation as the lungs contract.

Bronchial Isolation Device Delivery System. As discussed above, thebronchial isolation device is deployed in the bronchial passageway usinga delivery catheter 110, which is inserted into the bronchial passagewaythrough the patient's trachea. In one embodiment, the delivery catheter110 is inserted directly into the trachea and bronchial passageway. Inanother embodiment, shown in FIG. 1, a bronchoscope 120 assists in theinsertion of the delivery catheter 110 through the trachea and into thebronchial passageway. The method that uses the bronchoscope 120 isreferred to as the “transcopic” method. According to the transcopicmethod, the delivery catheter 110 is inserted into the working channelof the bronchoscope 120, which is deployed to the bronchial passageway517 either before or after the delivery catheter has been inserted intothe bronchoscope 120.

As shown in FIGS. 1 and 6, in an exemplary embodiment the bronchoscope120 has a steering mechanism 125, a delivery shaft 130, a workingchannel entry port 135, and a visualization eyepiece 140. FIG. 1 showsthe bronchoscope 120 positioned with its distal end at the right primarybronchus 510. The delivery catheter 110 is positioned within thebronchoscope 120 such that the delivery catheter's distal end and theattached bronchial isolation device 115 protrude outward from the distalend of the bronchoscope 120, as shown in FIG. 1.

FIG. 6 shows an enlarged view of the bronchoscope 120, including thesteering mechanism 125, delivery shaft 130, working channel entry port135, and visualization eyepiece 140. In addition, the bronchoscope canalso include a fiber optic bundle mounted inside the length of thebronchoscope for transferring an image from the distal end to theeyepiece 140. In one embodiment, the bronchoscope also includes a cameraor charge-coupled device (CCD) for generating an image of the bronchialtree. FIG. 7 shows an enlarged view of the distal portion of thebronchoscope 120. A working channel 710 (sometimes referred to as abiopsy channel) extends through the delivery shaft 130 and communicateswith the entry port 135 (shown in FIG. 6) at the proximal end of thebronchoscope 120. The working channel 710 can sometimes be formed by anextruded plastic tube inside the body of the bronchoscope 120. Thebronchoscope 120 can also include various other channels, such as avisualization channel 720 that communicates with the eyepiece 140 andone or more illumination channels 730. It should be appreciated that thebronchoscope can have a variety of configurations and is not limited tothe embodiment shown in the figures. For example, in an alternativeembodiment, the working channel 710 may be formed of a flexible materialand temporarily or permanently attached to the outside of the deliveryshaft 130.

FIG. 8 shows one embodiment of the delivery catheter 110 for deliveringand deploying the bronchial isolation device 115 to a target location ina bronchial passageway. The delivery catheter 110 has a proximal end 810and a distal end 815 that can be deployed to a target location in apatient's bronchial passageway, such as through the trachea. Thecatheter 110 has an elongated outer shaft 820 and an elongated innershaft 825 that is slidably positioned within the outer shaft 820 suchthat the outer shaft 820 can slidably move relative to the inner shaft825 along the length of the catheter, as described in more detail below.

The following references describe exemplary delivery devices: U.S. Pat.No. 5,954,766 entitled “Body Fluid Flow Control Device”; U.S. patentapplication Ser. No. 09/797,910, entitled “Methods and Devices for Usein Performing Pulmonary Procedures”; U.S. patent application Ser. No.10/270,792, entitled “Bronchial Flow Control Devices and Methods ofUse”; and U.S. patent application Ser. No. 10/448,154, entitled“Guidewire Delivery of Implantable Bronchial Isolation Devices inAccordance with Lung Treatment”. The foregoing references are allincorporated by reference in their entirety and are all assigned toEmphasys Medical, Inc., the assignee of the instant application.

With reference still to FIG. 8, an actuation handle 830, is located atthe proximal end 810 of the catheter 110; The actuation handle 830 canbe actuated to slidably move the outer shaft 820 in a proximal directionrelative to the inner shaft 825 with the inner shaft 825 remaining fixedrelative to the actuation handle 830. During such movement, the outershaft 820 slides over the inner shaft 825. FIG. 8 shows a schematic viewof the actuation handle 830, which is described in more detail below.Generally, the handle 830 includes a first piece 835 and a secondactuation piece 840, which is moveable relative to the first piece 835.The outer shaft 820 of the catheter 110 can be moved relative to theinner shaft 825 by moving the first piece 835 of the handle 830 relativeto the second piece 840.

The inner shaft 825 of the catheter 110 can include a central guidewirelumen (not shown) that extends through the entire length of the catheter110. The central guidewire lumen of the inner shaft 825 is sized toreceive a guidewire, which can be used during deployment of the catheter110 to guide the catheter 110 to a location in a bronchial passageway.

With reference still to FIG. 8, a housing 850 is located at or near adistal end of the catheter 110 for holding therein the bronchialisolation device 115. In one embodiment, the housing 850 is attached toa distal end of the outer shaft 820 of the catheter 110 but not attachedto the inner shaft 825, which extends axially through the housing. Thehousing 850 defines an inner cavity that is sized to receive thebronchial isolation device 115 therein.

FIG. 9 shows an enlarged, perspective view of the distal portion of thecatheter 110 where the housing 850 is located. FIG. 10A shows a plan,side view of the distal portion of the catheter 110 where the housing850 is located. As shown in FIGS. 9 and 10A, the housing 850 is shapedto receive the bronchial isolation device therein and is open at adistal end and closed at a proximal end. The inner shaft 825 of thecatheter 110 protrudes through the housing 850 and can slidably moverelative to the housing 850. An ejection member, such as a flange 910,is attached at or near a distal end of the inner shaft 825. The flange910 is sized such that it can be received into the housing 850 so thatthe flange 910 can be withdrawn into the housing 850 to abut a proximalend of the housing. FIGS. 9 and 10A show the flange 910 positionedoutside of the housing 850.

As described below, the ejection member can be used to eject thebronchial isolation device 115 from the housing 850. The housing can bemanufactured of a rigid material, such as steel. The housing 850 canalso be flexible or collapsible. Although the housing 850 is shownhaving a cylindrical shape, it should be appreciated that the housing850 can have other shapes that are configured to receive the bronchialisolation device therein.

In one embodiment, a sizing element 925 is located at or near thehousing 850, as shown in FIGS. 10A and 10B. (For clarity ofillustration, FIG. 10B does not show the bronchial isolation device 115mounted in the housing 850 and does not show the inner shaft 825 of thedelivery catheter.) The sizing element 925 can be used to determinewhether the bronchial isolation device 115 in the housing 850 will fitwithin a particular bronchial passageway in a working manner. The sizingelement 925 comprises one or more extensions, such as first extensions930 a and second extensions 930 b that define distances L1 and L2,respectively. That is, the opposed, outer tips of the extensions 930 aare separated by a distance L1 and the opposed, outer tips of theextensions 930 b are separated by a distance L2. The distance L1corresponds to the diameter of the larger end of the functional diameterrange of the bronchial isolation device 115. That is, the distance L1 issubstantially equal to the largest possible diameter for a bronchialpassageway in which the bronchial isolation device can be functionallydeployed. The distance L2 corresponds to the diameter of the lower endof the functional diameter range of the bronchial isolation device 115.That is, the distance L2 is substantially equal to the smallest possiblediameter for a bronchial passageway in which the bronchial isolationdevice 115 can be functionally deployed. It should be appreciated thatthe extensions 930 can take on a variety of structures and shapes. Forexample, FIGS. 10A and 10B shows the extensions 930 comprising elongateprongs that extend radially outward from the catheter or the housing850.

In another embodiment, shown in FIG. 9, the extensions 930 of the sizingelement 925 comprise two or more loops 931 a and 931 b, which correspondto the extensions 930 a and 930 b, respectively. Each loop 931 forms anellipse having a long axis of a predetermined length. In the illustratedembodiment, the loop 931 a has a long axis of length L1 that is greaterthan the length L2 of the long axis of the second loop 931 b. Thus, thelarger length L1 of loop 931 a corresponds to the diameter of the largerend of the functional diameter range of the bronchial isolation device115. The shorter length L2 of loop 931 b corresponds to the diameter ofthe lower end of the functional diameter range of the bronchialisolation device.

As the delivery catheter 110 is inserted into the bronchial passageway,the sizing element 925 is used to determine whether or not the bronchialpassageway is within the functional range of the bronchial isolationdevice 115. For a bronchial passageway in which the sizing element ispositioned, if the opposed tips of the longer extensions 930 a (e.g.,the diameter loop 931 a) cannot simultaneously contact the wall of thebronchial passageway, then the bronchial isolation device 115 is toosmall to be implanted in that passageway. In other words, the bronchialpassageway is too large for the bronchial isolation device if the tipsof the longer extensions 930 a cannot simultaneously contact thebronchial wall when the extensions 930 a are centrally positioned withinthe bronchial passageway. If the opposed tips of the shorter extensions930 b can simultaneously contact the wall of the bronchial passageway,then the bronchial isolation device 115 is too large to be implanted inthe bronchial passageway in a working manner.

The extensions 930, such as the loops 931, can be constructed of variousmaterials. In one embodiment, the extensions are constructed of wire,etched from a flat plate, or by other methods. The extensions 930 can bemade of a flexible material, such as Nitinol, or a polymer or otherflexible material, such that the extensions fold down when inserted intoor retracted into the working channel of the bronchoscope. In oneembodiment, the extensions are manufactured of Pebax, which is apolyether-block co-polyamide polymer. Other flexible resins can be usedas well. Other configurations and shapes of the sizing element 925 arecontemplated, such as standing struts rather than loops, etc.

If the bronchial isolation device 115 is manufactured in more than onesize, the sizing element 925 can be made in different sizes tocorrespond with each size of bronchial isolation device 115. The rangeof bronchial lumen diameters in which different sizes of bronchialisolation device can be implanted can be chosen such that the rangesoverlap. For example, the smallest acceptable diameter for a larger sizeof bronchial isolation device can be smaller than the largest acceptablediameter for the next smaller size of bronchial isolation device. Eachsize can be delivered with a delivery catheter 110 that has a sizingelement 925 with extensions 930 that correspond to the functional rangeof the particular size of bronchial isolation device.

When multiple sizes of bronchial isolation devices 115 are available,each can be delivered with a delivery catheter 110 that incorporates asizing element 925 with extensions 930 of a size that correspond to themaximum and minimum acceptable bronchial lumen diameters for thatdevice. This would require that the physician or other medicalpractitioner implanting the bronchial isolation devices estimate thesize of the appropriate device for the target bronchial lumen prior toimplanting the first device. The corresponding catheter package wouldthen be opened, and the catheter inserted into the bronchoscope, and thesizing element 925 used to check the diameter of the target bronchiallumen.

If the operator has chosen the wrong size of device, the deliverycatheter 110 would have to be removed from the bronchoscope and the nextlarger or smaller catheter chosen. This procedure might require theoperator to use an extra delivery catheter and/or bronchial isolationdevice, and to spend extra time changing to the appropriately sizeddevice.

In an alternative embodiment, the sizing element 925 can be mounted onthe distal end of a sizing catheter 2300, as shown in FIG. 23, ratherthan on the distal end of the delivery catheter 110. The sizing cathetercomprises a flexible shaft 2320, a handle 2310 mounted to the proximalend of the flexible shaft 2320, and a sizing element 2330 mounted to thedistal end of the flexible shaft. The sizing catheter 2300 is insertedthrough a suitable delivery device (such as through the working channelof the bronchoscope or other endoscope), placed into the targetbronchial lumen, and used to size the target bronchial lumen prior tothe insertion of the delivery catheter 110 with the bronchial isolationdevice 115 loaded into the distal end of the catheter. In this way, theappropriate size of bronchial isolation device 115 would be chosen priorto opening any delivery catheter or bronchial isolation device packages.

The sizing catheter 2300 can be designed to size bronchial lumens forjust one size of bronchial isolation device 115. In this situation, aswith the sizing element 925, the sizing element 2330 is mounted to thedistal end of the sizing catheter 2300, and is comprised of two sets ofsizing extensions 930 a and 930 b, one corresponding to the minimumoperational diameter and one corresponding to the maximum operationaldiameter of the bronchial isolation device 115. Alternately, if thereare two sizes of bronchial isolation device 115, the sizing element 2330can be comprised of three sets of sizing extensions 2350 as shown inFIG. 24. The length X1 of the longest set of extensions 2350 acorrespond to the maximum diameter of the larger of the two sizes ofbronchial isolation devices 115. The length X3 of the shortest set ofextensions 2350 c correspond to the minimum diameter of the smaller ofthe two sizes of bronchial isolation devices 115. The length X2 of theintermediate set of extensions 2350 b corresponds to the transitiondiameter between the two bronchial isolation devices 115. If the lumenis larger in diameter than X2, then the larger of the two bronchialisolation devices is implanted, and if the lumen is smaller in diameterthan X2, than the smaller of the two bronchial isolation devices isimplanted.

If there are three different sizes of bronchial isolation devices, thenthe sizing catheter 2300 can be manufactured with four sets of sizingextensions. The smaller of the two intermediate sets of extensionscorrespond to the transition diameter between the smallest and theintermediate size bronchial isolation device, and the larger of the twointermediate sets of extensions correspond to the transition diameterbetween the intermediate and the largest size bronchial isolationdevice. Of course, the number of sizing extensions 2350 could beincreased appropriately as the number of bronchial isolation devicesizes increases, however at some point it would become impractical toadd additional sizing extensions to the catheter.

More than one size of sizing catheter can be manufactured to solve thisproblem with each one covering the size range of a different set ofbronchial isolation devices. For example, one sizing catheter can bedesigned to size a small and a medium size of bronchial isolationdevice, and another sizing catheter designed to size the medium size anda large size of bronchial isolation devices. If there are four sizes ofdevice, one sizing catheter can be designed to size the first and secondsize of bronchial isolation device, and a second sizing catheter can bedesigned to size the third and fourth size of bronchial isolationdevices.

An additional feature of the sizing element 2330 is shown in FIG. 25. Abronchial lumen depth measuring extension 2360 comprising an elongatepost extends beyond the sizing elements 2350 along the axis of the shaft2320. The length of the depth measuring element 2360 is “Y” and thiscorresponds to the length of the portion of the bronchial isolationdevice 115 that contacts the bronchial lumen wall when the bronchialisolation device is positioned in the bronchial passageway. By placingthe distal tip of the depth measuring element 2360 against the distalend of the target bronchial lumen (this is often the tip of the carinaof the next more distal bifurcation), the operator can visualize thelocation of the sizing elements 2350. If the sizing elements areproximal of the proximal end of the target bronchial lumen, than thedevice is too long for the target bronchial lumen. If the sizingelements are distal to the proximal end of the target bronchial lumen,than the device will not be too long for the bronchial lumen.

As mentioned previously, the sizing element 2330 can be constructed of aflexible material that would allow the sizing extensions 2350 to foldback against the shaft 2320 in order to allow the sizing catheter 2300to be inserted through the working channel of a bronchoscope or otherendoscope for sizing, and then removed. The extensions can be formed ofa flexible metal such as stainless steel or nitinol, or of a polymersuch as thermo plastic elastomer.

The handle 2310 can be made of any appropriate material such as metal orplastic, and is preferably made with texture or ribs on the surface toallow it to be easily gripped with a gloved hand. The flexible shaft2320 is desirably flexible enough to allow it to pass through theworking channel of an articulated bronchoscope or other endoscope. Theshaft 2320 is also desirably stiff enough under compressive and tensileloads so that it may be pushed through the endoscope working channel andlater pulled to remove it. It is also desirably stiff enough in torsionso that the sizing element 2330 rotates in concert with rotation of thehandle 2310 without undo “windup” of the shaft.

To achieve the aforementioned features, there are a number of differentpossible construction techniques for the flexible shaft. The shaft canbe constructed from a solid flexible material such nylon or otherpolymer, or metal such as nitinol or stainless steel. It may be formedby coiling or braiding metal wire such as stainless steel or nitinol toform a shaft. It may be formed of a composition of two or more materialssuch as a braided wire shaft fused with a polymer tube. One compositionthat works particularly well is a solid PTFE (PolyTetraFluoroEthylene)core covered with a co-extrusion of nylon. Stainless steel wire is thenbraided on top of this core and a tubular polyether block amide (Pebax)extrusion is then fused over the wire so that the Pebax melts throughthe stainless steel wire and fuses to the nylon layer. This results in avery flexible shaft that transmits torque well to the sizing element2330, and is stiff along the shaft length to allow the catheter topushed through the endoscope working channel without kinking.

An optional feature of the sizing catheter 2300 is shown in FIG. 26. Thedistal end of the handle 2310 has a hole, indentation or cavity that issized to fit or receive the depth measuring element 2360. In order topackage the sizing catheter 2300, the catheter can be coiled and thedepth measuring element 2360 inserted into the hole in the handle 2310to both keep the catheter coiled and to protect the sizing element 2330from damage. The handle 2310 may also have a raised rim 2370 that actsto protect the sizing extensions 2350 from damage.

In use, the bronchial isolation device 115 is first inserted into thehousing 850. The bronchial isolation device 115 can be inserted into thehousing according to various methods and devices, some of which aredescribed in U.S. patent application Ser. No. 10/270,792, entitled“Bronchial Flow Control Devices and Methods of Use”, which is assignedto Emphasys Medical, Inc., the assignee of the instant application.After the bronchial isolation device 115 is inserted into the housing,the distal end of the delivery catheter 110 is deployed into a bronchialpassageway via the trachea such that the housing 850 is located at ornear the target location in the bronchial passageway, as shown in FIG.11A. Once the delivery catheter 110 and the attached bronchial isolationdevice 115 are located at the target location, an operator can eject thebronchial isolation device 115 from the housing 850 into the bronchialpassageway.

This process is described with reference to FIGS. 11A and 11B. FIG. 11Ashows a cross-sectional view of a bronchial passageway 1110 with thedeliver catheter 110 positioned therein. The distal end of the deliverycatheter 110, including the housing 850, is located at or near thetarget location L. Once the catheter is positioned as such, an operatoractuates the catheter handle 830 to slidably move the outer cathetermember 820 in a proximal direction relative to the location L, whilemaintaining the location of the bronchial isolation device 115, innershaft 825, and flange 910 fixed with respect to the location L. Theproximal movement of the outer shaft 820 causes the attached housing 850to also move in a proximal direction, while the flange 910 prevents thebronchial isolation device 115 from moving in the proximal direction.This results in the housing 850 sliding away from engagement with thebronchial isolation device 115 so that the bronchial isolation device115 is eventually entirely released from the housing 850 and implantedin the bronchial passageway at the target location L, as shown in FIG.11B.

During actuation of the actuation handle 830, the outer shaft 820 canundergo tension and the inner shaft 825 undergo compression due to therelative movement of the shafts and possible friction against theproximal movement of the outer shaft 820. This can result in an axialshortening of the inner shaft 825 and an axial lengthening of the outershaft 820. In order to compensate for this and to allow the device 115to be fully ejected from the housing 850, the flange 910 can beconfigured to over-travel a distance Y beyond the distal end of thehousing 850, as shown in FIG. 11B. The over-travel of the flange 910beyond the housing's distal end can create a potential problem duringwithdrawal of the delivery catheter 110, particularly in situationswhere the delivery catheter 110 is deployed in a location that requiresits distal end to bend at an acute angle. FIG. 12 shows such asituation, where the bronchial isolation device 115 is deployed at alocation in the bronchial tree 220 that requires the delivery catheter110 to bend at an acute angle with the flange 910 withdrawn entirelyfrom the housing 850. In such situations, the flange 910 can catch onthe tissue of the bronchial wall at a location 1210 inside the bend asthe operator pulls the catheter 110 out of the bronchial passageway.This can make it difficult for an operator to remove the deliverycatheter 110 from the bronchial passageway and can risk possible damageto the tissue if the operator continues to pull while the flange iscaught on the bend.

This problem can be overcome by limiting the travel of the flange 910relative to the housing 850 such that the flange 910 cannot move outwardof the distal end of the housing 850. One way this can be accomplishedis by limiting the travel of the inner shaft 825 at the distal end ofthe catheter 110. FIG. 13 shows a cross-sectional view of the distalregion of the catheter, showing the inner shaft 825 axially disposed inthe outer shaft 820. As mentioned, the flange 910 is attached to theinner shaft 825 and the housing 850 is attached to the outer shaft 820.The inner shaft 825 has a step 1405 and the housing 850 or outer shaft820 has a stop or ledge 1410. The step 1405 is spaced from the ledge1410 when the flange 910 is fully withdrawn in the housing 850. As theouter shaft 820 moves in the proximal direction, the step 1405eventually abuts the ledge 1410, which acts as a stop to limit anyfurther proximal movement of the outer shaft 820 relative to the innershaft 825. As shown in FIG. 14, the flange 910 is positioned just at thedistal end of the housing 850 when the stop position is reached. Thus,the flange 910 and housing 850 have a relative range of traveltherebetween.

In one embodiment, the flange 910 is limited from being distallypositioned at all past a distal edge of the housing. In anotherembodiment, the flange 910 can be distally positioned past the distalend of the housing only to the extent that the flange will not catchonto tissue during withdrawal of the delivery catheter. Thus, referringto FIG. 11B, the distance Y is sufficiently small to prevent or greatlyreduce the likelihood of bronchial wall tissue being caught or pinchedbetween the flange 910 and the housing 850 during withdrawal of thedelivery catheter 110. This eliminates the possibility of the flange 910catching or lodging on the bronchial tissue during removal of thedelivery catheter 110.

Actuation Handle. There is now described an actuation handle for thedelivery catheter that can be used to slide the outer shaft 820 (and theattached housing 850) relative to the inner shaft 825 while maintainingthe inner shaft 825 stationary relative to the handle. FIG. 15 shows aside view of an actuation handle 1510. In the illustrated embodiment,the actuation handle 1510 has an elongate shape suitable for graspingwithin an operator's hand. It should be appreciated, however, that theshape of the actuation handle 1510 can vary. The actuation handle 1510includes an actuation member, such as a slidable actuation slider 1515,that can be actuated to slide the outer shaft 820 relative to the innershaft 825 (the inner shaft is not shown in FIG. 15) during ejection ofthe bronchial isolation device 115. The actuation member can bepositioned on the handle 1510 such that an operator can grasp the handlewith a single hand and also move the actuation member using a finger orthumb of the same hand. For example, in the embodiment shown in FIG. 15,the slider 1515 is positioned along the side of the actuation handle1510 so that the operator's thumb can be used to move the slider 1515.Other configurations can be used.

FIG. 16 shows a cross-sectional view of the actuation handle 1510, whichincludes an actuation system for moving the outer shaft relative to thehandle. In one embodiment, the actuation system comprises a rack andpinion system for effecting movement of the outer shaft 820 relative tothe inner shaft 825. The actuation slider 1515 is coupled to theactuation system. The actuation slider 1515 is slidably positionedinside an elongate slot 1605 in the actuation handle 1510. A distal endof the actuation slider 1515 abuts or is attached to a first rack 1610that is also slidably mounted in the elongate slot 1605. The first rack1610 has a first edge with teeth that mesh with corresponding teeth on afirst pinion 1615. The first pinion 1615 is engaged with a second pinion1620 having teeth that mesh with a second rack 1625 mounted in anelongate slot 1628. The second rack 1625 is attached to the outer shaft820 of the delivery catheter 110 such that movement of the second rack1625 corresponds to movement of the outer shaft 820. That is, when thesecond rack slidably moves in the proximal direction or distaldirection, the outer shaft 820 also moves in the proximal or distaldirection, respectively. The inner shaft 825 is fixedly attached to thehandle 1510, such as by using adhesive or through a friction fit. Thefirst rack, second rack, first pinion, and second pinion collectivelyform a rack and pinion system that can be used to transfer distalmovement of the actuation slider 1515 to proximal movement of the outershaft 820 while the inner shaft 825 remains stationary relative to thehandle 1510, as described below.

The actuation slider 1515 can be positioned in an initial position, asshown in FIG. 16. When the actuation slider 1515 is in the initialposition, the flange 910 is fully withdrawn inside the housing 950 (asshown in FIG. 13). In one embodiment, the actuation slider 1515 is atthe proximal end of the handle when in the initial position, although itshould be appreciated that the initial position can vary. When theactuation slider 1515 slidably moves in the distal direction(represented by the arrow 1630 in FIG. 16) from the initial position,the rack and pinion system causes the outer shaft 820 to slidably movein the proximal direction (represented by the arrow 1635 in FIG. 16),and vice-versa, while the inner shaft 825 remains stationary relative tothe handle. More specifically, movement of the actuation slider 1515 inthe distal direction 1630 moves the rack 1610 in the distal direction,which drives the first pinion 1615 and which, in turn, drives the secondpinion 1620. The gearing between the second pinion 1620 and the secondrack 1625 causes the second rack 1625 to move in the proximal direction1635 through the slot 1628. As mentioned, the second rack 1625 isattached to the outer shaft 820 so that the outer shaft 820 moves in theproximal direction 1635 along with the second rack 1625. During suchmovement, a distal region of the outer shaft 820 slides into the handle1510. While this occurs, the inner catheter 825 (which is fixed to thehandle 1510) remains stationary relative to the handle 1510 while theouter shaft 820 moves. Thus, when the operator moves the slider 1515 inthe distal direction 1630, the outer shaft 820 (and the attached housing850) slides in the proximal direction, with the inner shaft 820 andflange 910 remaining stationary relative to the handle. The handle canbe fixed relative to the patient such that the handle, inner shaft,flange and bronchial isolation device remain fixed relative to thepatient during ejection of the bronchial isolation device from thehousing.

The gear ratio between the first pinion 1615 and second pinion 1620 canbe varied to result in a desired ratio of movement between the actuationslider 1515 and the outer catheter 820. For example, the first pinion1615 can have a larger diameter than the second pinion 1620 so that theouter shaft 820 (and the attached housing 850) are withdrawn in theproximal direction at a slower rate than the actuation slider 1515 isadvanced in the distal direction. The gear ratio can also be varied toreduce the force required to move the actuation slider 1515 and therebymake it easier for an operator to control ejection of the bronchialisolation device 115 from the housing 850. The ratio between the pinionscan be altered to make the withdrawal of the outer shaft faster, slower,or the same speed as the actuation slider movement. In one embodiment,the rack and pinion system is configured such that a 2:1 force reductionoccurs such that the actuator slider moves about twice the distance thatthe outer shaft 820 is moved. For example, if the slider is moved aninch in the distal direction, then the outer shaft and the attachedhousing moves about half an inch in the proximal direction, andvice-versa.

The handle 1510 can include a safety lock that retains the actuationslider 1515 (or any other type of actuation member) in the initialposition until the operator applies a force to the actuation slidersufficient to disengage the safety lock. The safety lock preventsinadvertent deployment of the bronchial isolation device either byinadvertent movement of the actuation slider in the distal direction orby inadvertent movement of the outer shaft 820 in the proximal directionrelative to the handle. Inadvertent proximal movement of the outer shaft820 can possibly occur when the delivery catheter 110 is being advancedinto the patient's trachea, which can cause resistance to be applied tothe outer shaft 820 by an anesthesia adaptor valve, endrotracheal tube,or the lung.

In one embodiment, the safety lock comprises one or more magnetspositioned in the actuation handle 1510. FIG. 17 shows a partial,cross-sectional view of the proximal end of the handle 1510 with theactuation slider 1515 positioned distally of the initial position. Afirst magnet 1710 is located on the handle 1510 near the initiallocation of the actuation slider 1515. A second magnet 1715 is locatedon or in the actuation slider 1515. The magnets 1710, 1715 are orientedsuch that an attractive magnetic force exists therebetween. When theactuation slider 1515 is in the initial position, the magnetic forcebetween the magnets 1710,1715 retains the actuation slider 1515 in theinitial position until the operator applies a force to the slider 1515sufficient to overcome the magnetic force and move the slider 1515 outof the initial position.

It should be appreciated that configurations other than magnets can beemployed as the safety lock. One advantage of magnets is that theattractive force between the magnets 1710, 1715 automatically increasesas the actuation slider moves toward the initial position. If theactuation slider happens to be out of the initial position when thebronchial isolation device is loaded into the housing 850, the actuationslider 1515 is driven back toward the initial position as the bronchialisolation device is loaded into the housing 850. The magnetic attractionbetween the first and second magnets 1710, 1715 automatically engagesthe safety lock when the actuation slider 1515 moves into the initialposition.

The safety lock can include an additional feature wherein the operatormust depress the actuation slider 1515 in order to disengage the sliderfrom the initial position. As shown in FIG. 17, the slot 1605 in theactuation handle 1510 has an opening 1712. The actuation slider 1515moves outward and sits in the opening 1712 when in the initial position.The operator must depress the slider 1515 to move the actuation slider1515 out of the opening in order to disengage the slider from theinitial position and slide the actuation slider 1515 in the distaldirection.

Adjustment of Handle Position Relative to Bronchoscope. As discussedabove, according to the transcopic delivery method, the bronchoscope 120(shown in FIGS. 1, 6, 7) is used in deploying the delivery catheter 110into the bronchial passageway. Pursuant to this method, the deliverycatheter 110 is inserted into the working channel 710 of thebronchoscope 120 such that the delivery catheter's distal end is alignedwith or protrudes from the distal end of the bronchoscope 120. Thebronchoscope 120, with the delivery catheter 110 positioned as such, isthen inserted into the bronchial passageway via the patient's tracheasuch that the distal end of the delivery catheter is positioned at adesired location in the bronchial passageway, as shown in FIG. 1. Itshould be appreciated that the delivery catheter 110 can be insertedinto the bronchoscope 120 either before or after the bronchoscope hasbeen inserted into the bronchial passageway.

FIG. 18 shows an enlarged view of the distal region of the bronchoscope120 with the delivery catheter's distal end (including the housing 850)protruding outward from the working channel 710. The bronchial isolationdevice 115 is positioned within the housing 850. The bronchial isolationdevice 115 is a distance D from the distal end of the bronchoscope 120.Once the bronchoscope and delivery catheter are in the patient, theoperator may desire to adjust the distance D to fine tune the locationof the bronchial isolation device 115. However, it can also be desirableor even required to hold the actuation handle 1510, and thus the innershaft 825, stationary relative to the bronchoscope 120. This way, thebronchoscope 120 can be fixed relative to the patient's body, therebykeeping the bronchial isolation device 115 fixed relative to the targetlocation in the bronchial passageway.

FIG. 19 shows another embodiment of the actuation handle, referred to asactuation handle 1910, that can be used for transcopic delivery and thatcan be fixed relative to a bronchoscope while also allowing foradjustments in the distance D of FIG. 18 once the delivery device ispositioned in the bronchoscope. The actuation handle 1910 includes anactuation member in the form of a button 1915 that can be depressed inthe distal direction to move the outer shaft 820 of the deliverycatheter in the proximal direction. The handle includes an adjustmentmechanism that is used to adjust the position of the handle relative tothe bronchoscope. The adjustment mechanism comprises an elongatedbronchoscope mount 1920 that extends outwardly from the distal end ofthe actuation handle 1910 and extends at least partially over thecatheter outer shaft 820 such that the outer shaft can slide freelywithin the bronchoscope mount 1920. The bronchoscope mount 1920 extendsoutward from the handle a distance A. The bronchoscope mount 1920 isslidably moveable into or out of the handle 1910 such that it can bepushed into or pulled out of the handle 1910 along the axis of the mount1920 in order to adjust the distance A. In one embodiment thebronchoscope mount 1920 is biased outward, for example with a spring, sothat its tendency is to be fully extended outward from the handle 1910.A locking mechanism includes a lock, such as a lever 1925, that can bedepressed to lock the bronchoscope mount 1920 relative to the handle1910 when the distance A is adjusted to a desired amount, as describedbelow. Once the distance A is at a desired amount, the operator can lockthe bronchoscope mount 1920 relative to the handle to fix thebronchoscope mount 1920 relative to the handle 1910.

With reference to FIG. 20, the bronchoscope mount 1920 has a size andshape that is configured to sit within the entry port 135 of thebronchoscope working channel. In use, an operator can insert thebronchoscope mount 1920 into the entry port 135 such that it abuts andsits within the entry port 135. In this manner, the actuation handle1910 is fixed relative to the bronchoscope 120 with the catheter'sdistal end protruding a distance D from the bronchoscope's distal end(as shown in FIG. 20). The operator can then adjust the distance A bymoving the bronchoscope mount 1920 into or out of the handle 1910, suchas by pushing on the handle 1910 to decrease the distance A. By virtueof the outer and inner catheter shafts' attachment to the handle,adjustments in the distance A will correspond to adjustments in D. Thatis, as the operator decreases the distance A (FIG. 20), the catheterslides deeper into the bronchoscope so that the distance D (FIG. 18)increases, and vice-versa.

Once the desired distance A has been achieved, the bronchoscope mount1920 is locked by depressing the lever 1925. Thus, by adjusting thedistance A, the operator also adjusts the distance D (shown in FIG. 18)between the distal end of the bronchoscope 120 and the bronchialisolation device 115. This can be helpful where different brands ortypes of bronchoscopes have different length working channels. It alsoallows the operator to fine-tune the position of the housing 850 andbronchial isolation device in the bronchial passageway without movingthe bronchoscope. Other mechanisms for locking the movement of thebronchoscope mount 1920 are possible such as depressing and holding thelever 1925 to release the movement of the bronchoscope mount 1920,repositioning the bronchoscope mount 1920, and releasing the lever 1925to lock the bronchoscope mount 1920 in place.

Catheter Sheath. As discussed above, during use of the delivery catheter110 it can be desirable to fix the location of the inner shaft 825 (andthus the bronchial isolation device in the housing 850) relative to thepatient's body while proximally withdrawing the outer shaft 820 and thehousing 850 relative to the bronchial passageway to eject the bronchialisolation device, as shown in FIGS. 11A and 11B. Given that the outershaft 820 moves proximally relative to the bronchial passageway duringthe foregoing process, the outer shaft 820 can encounter resistance toproximal movement due to friction with devices or body passageways inwhich the delivery device is positioned. For example, the outer surfaceof the outer shaft 820 can encounter frictional resistance against ananesthesia adaptor through which the outer shaft is inserted. Theanesthesia adapter is a fitting that permits the bronchoscope anddelivery catheter to be inserted into the lung without leakage ofventilated oxygen, anesthesia gases, or other airway gases. The adaptertypically has a valve through which the delivery catheter orbronchoscope is inserted. The valve seals against the outer surface ofthe outer shaft 820 to prevent air leaks. This seal can provideresistance against proximal movement of the outer shaft 820 duringejection of the bronchial isolation device from the housing 850. Suchresistance to proximal movement of the outer shaft 820 is undesirable,as it can result in the bronchial isolation device 115 being deployed ina location distal of the target location in the bronchial passageway.

FIG. 21 shows an embodiment of the delivery catheter 110, which includesa deployment sheath 2110 that reduces or eliminates the resistance toproximal movement of the catheter outer shaft 820 during ejection of thebronchial isolation device 115. The deployment sheath 2110 is a sheathhaving an internal lumen in which the outer shaft 820 is slidablypositioned. The sheath 2110 is fixed at a proximal end 2112 to theactuation handle 815. FIG. 21 shows the actuation handle 815, althoughthe sheath 2110 can be used with any type of handle. Furthermore, itshould be appreciated that the sheath 2110 is not limited to use withdelivery catheters that deploy bronchial isolation devices, but canrather be used with various types of catheters. For example, the sheathconfiguration can be used in combination with catheters suitable for usein venous, arterial, urinary, billiary, or other body passageways. Thesheath 2110 extends over the outer shaft 820 a distance X. The distanceX can vary. In one embodiment, the distance X is long enough to extendto locations where the outer shaft is likely to encounter frictionalresistance to movement, such as at the anesthesia adapter, if present.However, when used with a delivery catheter having a housing 850, thedistance X is such that the distal end of the sheath does not interferewith the housing 850 being fully withdrawn in the proximal direction.

The sheath 2110 can have a very thin wall to minimize its contributionto the overall diameter of the delivery catheter 110. In one embodiment,the sheath 2110 has a wall thickness in the range of approximately 0.002inches to approximately 0.004 inches. The sheath 2110 is manufactured ofa material that is lubricous to minimize resistance to the outer shaft820 sliding inside the sheath 2110. The sheath material also has astiffness that resists crumpling when a compressive load is placed alongthe length of the sheath (such as when the sheath is possibly pinched orgrabbed to fix its position relative to the anesthesia adapter duringejection of the catheter from the housing, as described below). Thecompressive forces can come from the possibility that the outer shaft ispinched when the sheath is pinched, and thus when the handle is actuatedand the outer shaft starts to move towards the handle, the sheath iscompressed]. The sheath 2110 can be manufactured of various materials,such as, for example, polyimide, Teflon doped polyimide,PolyEtherEtherKetone (PEEK), etc.

In use, the delivery catheter 110 is positioned in the patient's lungthrough the trachea, such as described above. This can involve thedelivery catheter 110 being positioned through a device such as abronchoscope or through an anesthesia adapter 2210, such as shown in thepartial view of FIG. 22. The sheath 2110 is located between theanesthesia adapter 2210 and the outer shaft 820 (not shown in FIG. 22)such that the sheath 2110 provides a lubricous shield between the outershaft 820 and the anesthesia adapter. Thus, the outer shaft 820 can beproximally moved using the actuation handle without the outer shaft 820encountering frictional resistance from contact with the anesthesiaadapter (or any other object or device in which the sheath and outershaft are positioned). If desired, the operator can grab or pinch thecatheter 110 (as represented by the arrows 2215 in FIG. 22) through thesheath 2110 at the entrance of the anesthesia adapter 2210 to fix thelocation of the sheath 2110 (and thus the location of the handle and theinner shaft) relative to the patient and/or anesthesia adaptor. As thesheath 2110 is made of a relatively rigid and lubricous material, theouter shaft 820 is free to slide through the sheath in the proximaldirection as the sheath is grabbed.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

1. (canceled)
 2. A method for delivering a bronchial isolation deviceinto a pulmonary airway, the device comprising: advancing a deliverycatheter through a bronchoscope so that a distal portion of the deliverycatheter extends out of a distal opening in the bronchoscope and intothe airway, wherein the bronchial isolation device is housed in thedistal portion of the delivery catheter; positioning sizing elementsextending radially outward from the distal portion of the deliverycatheter at or near a target location in the airway for delivering thebronchial isolation device; visualizing with the bronchoscope whether alarger-diameter sizing element on the delivery catheter is contacting awall of the airway in the target location and a smaller-diameter sizingelement is not contacting the wall of the airway; and delivering thebronchial isolation device at the target location if the larger-diametersizing element is contacting the wall of the airway and thesmaller-diameter sizing element is not contacting the wall.
 3. A methodas in claim 1, further comprising: removing the delivery catheterwithout delivering the bronchial isolation device if neither thelarger-diameter nor the smaller-diameter sizing element contacts theairway wall; advancing a second delivery catheter with a larger-diameterbronchial isolation device through the bronchoscope; repeating thepositioning and visualizing steps using the second delivery catheter;and delivering the larger-diameter bronchial isolation device at thetarget location.
 4. A method as in claim 1, further comprising: removingthe delivery catheter without delivering the bronchial isolation deviceif both the larger-diameter and the smaller-diameter sizing elementcontact the airway wall; advancing a second delivery catheter with asmaller-diameter bronchial isolation device through the bronchoscope;repeating the positioning and visualizing steps using the seconddelivery catheter; and delivering the smaller-diameter bronchialisolation device at the target location.
 5. A method as in claim 1,wherein positioning the sizing elements comprises positioning two longerextensions positioned opposite one another on the delivery catheter andtwo shorter extensions positioned opposite one another on the deliverycatheter.
 6. A method as in claim 1, wherein the positioning stepcomprises placing a distal tip of the delivery catheter at a distal endof the airway targeted for delivery of the bronchial isolation device,the method further comprising visualizing with the bronchoscope aposition of the sizing elements relative to the targeted airway.
 7. Amethod as in claim 6, wherein the distal portion of the deliverycatheter comprises a bronchial lumen depth measuring extension.
 8. Amethod as in claim 6, wherein placing the distal tip comprisescontacting the tip with a tip of a carina of a next more distal airwaybifurcation.
 9. A method for delivering a bronchial isolation deviceinto a pulmonary airway, the device comprising: advancing a sizingcatheter through a bronchoscope so that a distal portion of the sizingcatheter extends out of a distal opening in the bronchoscope and intothe airway; positioning sizing elements extending radially outward fromthe distal portion of the sizing catheter at or near a target locationin the airway for delivering the bronchial isolation device; visualizingwith the bronchoscope a larger-diameter sizing element on the sizingcatheter contacting a wall of the airway in the target location and asmaller-diameter sizing element not contacting the wall of the airway;removing the sizing catheter from the bronchoscope; advancing a deliverycatheter housing the bronchial isolation device sized according todiameters of the larger- and smaller-diameter sizing elements throughthe bronchoscope to the target location; and delivering the bronchialisolation device at the target location.
 10. A method as in claim 10,wherein advancing the delivery catheter comprises advancing the catheteruntil a distal tip of the catheter contacts a tip of a carina of a nextmore distal airway bifurcation, the method further comprising confirmingthat the bronchial isolation device has a desired length by visualizinga position of the sizing elements relative to the target location in theairway.